Single-use plantar plate graft augmentation kit and method of repairing plantar plate tears through graft augmentation

ABSTRACT

A plantar plate augmentation kit assembly and method of repairing plantar plate tears through augmentation provides an assembly of tools used to augment a plantar plate with a soft tissue graft, and specifically an Artelon Graft. The kit assembly includes a plantar plate drill guide for aligning a drill bit and K-wires over a damaged area of a plantar plate. The assembly also includes a plantar plate joint distractor for separating tissue, at least two K-wires that serve as anchors to the tissue, a drill bit for driving the graft into the tissue. The assembly also includes a graft passer for retaining and manipulating the graft. Further included are at least two interference-type screws and a screw driver for manipulating the interference-type screws. These components are stored in a storage container that includes an outer housing and multiple inner recesses shaped and sized to frictionally fit the tools.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Patent ApplicationNo. 62/644,401 filed Mar. 17, 2018, the entirety of which isincorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to a plantar plate augmentationkits and assemblies and method of repairing plantar plate tears throughaugmentation, and, more particularly, relates to a kit assembly andmethod that repairs plantar plate tears through use of an FDA approvedsoft tissue graft that augments the plantar plate structure through useof a plantar plate drill guide, a plantar plate joint distractor, atleast two K-wires, a drill bit, a graft passer, at least twointerference-type screws, a screw driver, and a soft tissue graft.

BACKGROUND OF THE INVENTION

It is known in the art that the plantar fascia is the flat band oftissue (ligament) that connects the heel bone to the toes. The plantarfascia supports the arch of your foot. If a person strains the plantarfascia, it gets weak, swollen, and irritated. Consequently, the heel orthe bottom of the foot hurts when standing or walking.

Generally, the plantar plate is a ligament that is situated on theunderside of the metatarsal phalangeal joints at the ball of the feet. Aplantar plate tear is a common injury of the forefoot which is caused byrepetitive overload.

The plantar plate is a fibrocartilaginous tissue that is the directinsertion of the plantar fascia into the base of the phalanges of thelesser toes. Plantar plate injuries are a common foot condition that hasbeen a challenging procedure for physicians to master. Traditionally,there are complicated suture-based repair techniques that are difficultto perform and are based on a suture repair, and not graft augmentation.

To aid in overcoming surgical challenges associated with plantar plateinjuries, the present invention provides a planter plate graftaugmentation kit, assembly, and method of use. Specifically, in oneembodiment, the kit described below, which may be designed for singleuse by a physician, is designed to provide a surgeon a fast, easy, andeffective way to repair the plantar plate tear. This technique uses anFDA approved soft tissue graft that augments the plantar platestructure.

Therefore, a need exists to overcome the problems with the prior art asdiscussed above.

SUMMARY OF THE INVENTION

The invention provides a single-use plantar plate augmentation kitassembly and method of repairing plantar plate tears throughaugmentation that overcomes the hereinafore-mentioned disadvantages ofthe heretofore-known devices and methods of this general type and thatprovides an assembly of tools used to augment a plantar plate with asoft tissue graft, and specifically an Artelon graft.

While the specification concludes with claims defining the features ofthe invention that are regarded as novel, it is believed that theinvention will be better understood from a consideration of thefollowing description in conjunction with the drawing figures, in whichlike reference numerals are carried forward. It is to be understood thatthe disclosed embodiments are merely exemplary of the invention, whichcan be embodied in various forms.

The present invention provides a novel and efficient plantar plateaugmentation kit assembly and method of repairing plantar plate tearsthrough augmentation. Embodiments of the invention provide a plantarplate drill guide, a plantar plate joint distractor, at least twoK-wires, a drill bit, a graft passer, at least two interference-typescrews, a screw driver, and a soft tissue graft. These components arestored in a storage container which may effectively house and store thetools necessary to provide the planter plate graft surgical procedure.

In addition, embodiments of the invention, the kit assembly provides acontainer to organize and carry the tools and components describedherein. The container includes an outer housing and multiple innerrecesses shaped and sized to frictionally fit the tools. The innerrecesses help prevent inadvertent dislodging of the same while intransport or in the operating room.

In addition, embodiments of the invention provides a plantar plate drillguide that positions over the damaged area of the plantar plate. Theplantar plate drill guide serves to align a drill bit and K-wires intothe plantar plate during augmentation. The plantar plate drill guideincludes a main body having a support member with a drill receivingplatform. The support member may be disposed at a substantiallyorthogonal orientation with respect to the body and may be coupled tothe body.

In addition, the plantar plate drill guide has a plurality of channelsthat may be beneficially canted at various angles to provide for variousinsertion angles of a removable drill insertion member and/or the drillitself.

In accordance with another feature, an embodiment of the presentinvention includes a plantar plate joint distractor that spreads humantissue or organs.

In accordance with another feature, the plantar plate joint distractormoves between a closed configuration and an open configuration along aspreader opening path.

In accordance with another feature, the plantar plate joint distractoris defined by two apertures to receive at least two K-wires.

In accordance with a further feature of the present invention, anembodiment of the present invention includes a drill bit beingapproximately 2.7 mm in diameter, and shaped and sized for insertionwithin the drill insertion member.

In accordance with a further feature of the present invention, anembodiment of the present invention includes a graft passer tofacilitate in the handling of the graft.

In accordance with a further feature of the present invention, the graftpasser has a handle end for controlling the graft passer, and a loopthat retains the graft during manipulation.

In accordance with a further feature of the present invention, anembodiment of the present invention includes at least two K-wires, eachapproximately 0.45 inches in diameter.

In accordance with a further feature of the present invention, anembodiment of the present invention includes two interference typescrews with a screw driver used in the surgical procedure.

In accordance with the present invention, a method of repairing plantarplate tears through augmentation includes an initial Step of cutting anincision above a damaged area of a plantar plate. The method may furthercomprise a Step of spreading the tissue at or near the plantar platewith a plantar plate joint distractor, whereby the plantar plate jointdistractor is selectively expanded to an open configuration along aspreader opening path.

Another Step includes positioning a plantar drill guide over the plantarplate, the plantar drill guide comprising a main body, a support member,and a drill receiving platform, the main body being defined by aplurality of channels sloped at multiple angles. In some embodiments, aStep comprises inserting a drill insertion member into one of thechannels, the selected channel being dependent on a drilling angle overthe tissue. A Step includes passing a drill bit through the drillinsertion member. A Step may include drilling, with the drill bit, thetissue at or near the damaged area of the plantar plate.

In some embodiments, a Step comprises positioning a graft over a damagedarea of the plantar plate, whereby the graft augments the damaged areaof the plantar plate. The method may further comprise a Step of passing,with a graft passer, at least two K-wires through the graft and theplantar plate. A Step includes manipulating, with a screw driver, atleast two interference-type screws through the graft and the plantarplate. A final Step includes removing, after a duration, the K-wiresfrom the plantar plate, whereby the damaged area of the plantar plate ishealed.

Although the invention is illustrated and described herein as embodiedin a plantar plate augmentation kit assembly and method of repairingplantar plate tears through augmentation, it is, nevertheless, notintended to be limited to the details shown because variousmodifications and structural changes may be made therein withoutdeparting from the spirit of the invention and within the scope andrange of equivalents of the claims. Additionally, well-known elements ofexemplary embodiments of the invention will not be described in detailor will be omitted so as not to obscure the relevant details of theinvention.

Other features that are considered as characteristic for the inventionare set forth in the appended claims. As required, detailed embodimentsof the present invention are disclosed herein; however, it is to beunderstood that the disclosed embodiments are merely exemplary of theinvention, which can be embodied in various forms. Therefore, specificstructural and functional details disclosed herein are not to beinterpreted as limiting, but merely as a basis for the claims and as arepresentative basis for teaching one of ordinary skill in the art tovariously employ the present invention in virtually any appropriatelydetailed structure. Further, the terms and phrases used herein are notintended to be limiting; but rather, to provide an understandabledescription of the invention. While the specification concludes withclaims defining the features of the invention that are regarded asnovel, it is believed that the invention will be better understood froma consideration of the following description in conjunction with thedrawing figures, in which like reference numerals are carried forward.The figures of the drawings are not drawn to scale.

Before the present invention is disclosed and described, it is to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only and is not intended to belimiting. The terms “a” or “an,” as used herein, are defined as one ormore than one. The term “plurality,” as used herein, is defined as twoor more than two. The term “another,” as used herein, is defined as atleast a second or more. The terms “including” and/or “having,” as usedherein, are defined as comprising (i.e., open language). The term“coupled,” as used herein, is defined as connected, although notnecessarily directly, and not necessarily mechanically. The term“providing” is defined herein in its broadest sense, e.g.,bringing/coming into physical existence, making available, and/orsupplying to someone or something, in whole or in multiple parts at onceor over a period of time.

As used herein, the terms “about” or “approximately” apply to allnumeric values, whether or not explicitly indicated. These termsgenerally refer to a range of numbers that one of skill in the art wouldconsider equivalent to the recited values (i.e., having the samefunction or result). In many instances these terms may include numbersthat are rounded to the nearest significant figure. In this document,the term “longitudinal” should be understood to mean in a directioncorresponding to an elongated direction of the assembly kit.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, where like reference numerals refer toidentical or functionally similar elements throughout the separate viewsand which together with the detailed description below are incorporatedin and form part of the specification, serve to further illustratevarious embodiments and explain various principles and advantages all inaccordance with the present invention.

FIG. 1 is a top view of an exemplary plantar plate augmentationassembly, showing individual close-up views of the tools and/orcomponents used in the assembly, in accordance with the presentinvention;

FIG. 2 is a top view of an exemplary plantar plate augmentation kit, inaccordance with the present invention;

FIG. 3 is a perspective view of an exemplary plantar plate drill guide,in accordance with the present invention;

FIG. 4 is an elevated side view of the plantar plate drill guide, shownin FIG. 3, in accordance with the present invention;

FIG. 5 is a perspective view of the plantar plate drill guide, showingthe removable drill insertion member pivoting at different angles, inaccordance with the present invention;

FIG. 6 is a perspective view of an exemplary plantar plate jointdistractor, in accordance with the present invention;

FIG. 7 is a perspective view of the plantar plate joint distractor,shown in FIG. 6 in a closed position, in accordance with the presentinvention;

FIG. 8 is a perspective view of the plantar plate joint distractor,shown in FIG. 6 in an open position, in accordance with the presentinvention;

FIG. 9 is a perspective view of an exemplary drill bit, in accordancewith the present invention;

FIG. 10 is a view of the plantar plate joint distractor, in accordancewith the present invention;

FIG. 11 is a top view of an exemplary graft passer, in accordance withthe present invention;

FIG. 12 is a perspective view of the graft passer, shown in FIG. 11, inaccordance with the present invention;

FIG. 13 is a perspective view of a K-wire, in accordance with thepresent invention;

FIG. 14 is an elevated side view of an exemplary interference typescrew, in accordance with the present invention;

FIG. 15 is a perspective view of an interference type screw, inaccordance with the present invention;

FIG. 16 is an elevated side view of an exemplary screw drivermanipulating the interference type screw, in accordance with the presentinvention;

FIG. 17 is a perspective view of an exemplary screw driver manipulatingthe interference type screw, in accordance with the present invention;

FIG. 18 is an elevated side view of an exemplary soft tissue graft, inaccordance with the present invention;

FIG. 19 is a perspective view of the soft tissue graft shown in FIG. 18,in accordance with the present invention;

FIG. 20 is a perspective view of a foot, showing the plantar fascia,plantar plate, and tendons, in accordance with the present invention;

FIG. 21 is a perspective view of one step of the augmentation procedure,showing the plantar plate joint distractor separating skin to access thedamaged area of the plantar plate, in accordance with the presentinvention;

FIG. 22 is a side perspective view of a step of the augmentationprocedure, showing the plantar plate drill guide positioned over theplantar plate, in accordance with the present invention;

FIG. 23 is a top perspective view of a step of the augmentationprocedure, showing the plantar plate drill guide positioned over theplantar plate, in accordance with the present invention;

FIG. 24 is a perspective view of a step of the augmentation procedure,showing a graft being augmented across the damaged area of the plantarplate, in accordance with the present invention;

FIG. 25 is a perspective view of a step of the augmentation procedure,showing the graft being manipulated across the plantar plate, inaccordance with the present invention;

FIG. 26 is a perspective view of a step of the augmentation procedure,showing a K-wire pulling the graft across the plantar plate, inaccordance with the present invention;

FIG. 27 is a perspective view of a step of the augmentation procedure,showing a drill driving the graft into the plantar plate, in accordancewith the present invention; and

FIG. 28 illustrates a flowchart of an exemplary method of repairingplantar plate tears through augmentation, in accordance with the presentinvention.

DETAILED DESCRIPTION

While the specification concludes with claims defining the features ofthe invention that are regarded as novel, it is believed that theinvention will be better understood from a consideration of thefollowing description in conjunction with the drawing figures, in whichlike reference numerals are carried forward. It is to be understood thatthe disclosed embodiments are merely exemplary of the invention, whichcan be embodied in various forms.

The present invention provides a novel and efficient single-use assemblykit and method of use for planter plate graft augmentation. Referringnow to FIG. 1, one embodiment of the present invention is shown in aperspective top angle view. FIG. 1, along with the other figures herein,shows several advantageous features of the present invention, but, aswill be described below, the invention can be provided in severalshapes, sizes, combinations of features and components, and varyingnumbers and functions of the components. The first example of a plantarplate graft augmentation assembly, as shown in FIG. 1, includes aplantar plate drill guide, a plantar plate joint distractor, at leasttwo K-wires, a drill bit, a graft passer, at least two interference-typescrews, a screw driver, and a soft tissue graft. These tools andcomponents are stored in a storage container 200 that effectively housesand store the tools necessary to provide the planter plate graftsurgical procedure.

The present invention provides a novel and efficient single-use assemblykit 100 and method 2800 of use for planter plate graft augmentation.Specifically, with reference to FIGS. 1 and 2, the assembly kit 100provides a container, which may be designed for single use, provideinstruments to perform the planter plate graft augmentation. The storagecontainer 200 effectively houses and stores the tools necessary toprovide the planter plate graft surgical procedure. In one embodiment,the container may have an outer housing 202 and multiple inner recesses204 a-n that are shaped and sized to frictionally fit the tools toprevent inadvertent dislodging of the same while in transport or in theoperating room. The inner recesses 204 a-n may be configured from a foamor resilient material.

The assembly kit 100 may contain a plantar plate drill guide 300 (shownin more detail in FIGS. 3-5), a plantar plate joint distractor 600(shown in more detail in FIGS. 6-8), at least two K-wires 1300 a-b(shown in more detail in FIG. 13), a drill bit 900 approximately 2.7 mmin diameter (shown in more detail in FIGS. 9-10), a graft passer 1100(shown in more detail in FIGS. 11-12), two interference type screws 1400a-b operable with a screw driver 1600 (shown in more detail in FIGS.14-17). The above tools are used to augment a soft tissue graft 1800(shown in more detail in FIGS. 18-19). It is the intent of the presentinvention to provide a cost-effective assembly kit that is easy to useand to allow the surgeon to achieve consistent operative results.

FIG. 1 references a collection of components used for the plantar plateaugmentation. FIG. 2 shows a storage container 200 that store the tools.FIGS. 3-19 depict individual close-up views of the tools and/orcomponents used in the assembly kit 100 as discussed herein. FIG. 20references an exemplary method 2800 of use for planter plate graftaugmentation.

Looking ahead to FIG. 20, it is recognized that the plantar plate 2002is a fibrocartilaginous tissue that is the direct insertion of theplantar fascia 2000 into the base of the phalanges of the lesser toes.The plantar plate 2002 is situated on the underside of the metatarsalphalangeal joints at the ball of the feet, below the second cuneiform2010 and the second metatarsal 2008. The plantar plate 2002 comprises anFDB tendon 2006 and an FDL tendon 2004. These tendons can tear or bestrained when heavy use or loads are applied to the foot. Plantar plate2002 injuries are a common foot condition that has been a challengingprocedure for physicians to master. Traditionally, there are complicatedsuture based repair techniques that are difficult to perform and arebased on a suture repair, and not graft augmentation.

To aid in overcoming surgical challenges associated with plantar plateinjuries, the present invention provides a planter plate graftaugmentation kit 100 and method 2800 of use. Specifically, in oneembodiment, the kit described below, which may be designed for singleuse by a physician, is designed to provide a surgeon a fast, easy, andeffective way to repair the plantar plate tear. This technique uses anFDA approved soft tissue graft that augments the plantar platestructure, and specifically for reinforcement and augmentation of tissuerepair, e.g. ligaments, tendons, general soft tissues.

Those skilled in the art will recognize that tendons are tough, fibrousbands of tissue that attach muscles to bones. Tendons can become torn orfrayed because of overuse or injury. The graft tissue used in thepresent invention is efficacious for protecting and reinforcing adamaged tendon in the plantar plate, helping it heal. In onenon-limiting embodiment, the graft used is an FDA approved Artelongraft. The Artelon graft may be of a porous polyurethane material andacts as a scaffold which promotes ingrowth of native human tissue.Typically, the Artelon graft degrades over a period of around 5-7 yearsduring which time most of the material is replaced by native humantissue.

With reference specifically to FIG. 3, an exemplary and unique plantarplate drill guide 300 is shown. The plantar plate drill guide 300 isused to position over a damaged area of a plantar plate 2002, so as toalign a drill for drilling therein. The plantar plate drill guide 300comprises a main body 302 that is flat and linear. The main body 302 isdefined by multiple channels 308 a-n. The channels may have a circularshape to accommodate a circular drill, as described below.

The plantar plate drill guide 300 also includes a support member 304 isdisposed at a substantially orthogonal orientation with respect to themain body 302 (FIG. 4). The support member 304 holds the main body 302and channels 308 a-n over a damaged area of the plantar plate 2002. Inthis manner, the channel, and the drill therein is oriented to a desiredangle. The support member 304 is coupled to the main body 302 using afastener 314, adhesive, or compression fitting.

Looking now at FIG. 5, the plantar plate drill guide 300 furtherprovides a support member 304 that includes a drill receiving platform306. The channels 308 a-n may be beneficially canted at various anglesto provide various insertion angles of a removable drill insertionmember 310 and/or a drill bit 900. This allows drilling into the plantarplate 2002 at incremental angles.

The drill insertion member 310 is a hollow cylindrical piece that may beremovably couplable to the channels in the main body 302 using frictionfitting and/or a fastener. The drill insertion member 310 can be seendefining the channel that accommodates a drill used in connection withthe surgical procedure. The drill insertion member 310 may include ahollow body having a proximal opening 312 a and distal opening 312 b.

The orientation of the drill insertion member 310, particularly thedistal opening 312 b, provides an inlet for a drill bit 900 or otherdrilling device to be aligned with the receiving drill receivingplatform 306. Once the drill bit passes through, a drill can then rotatethe drill bit at the desired angle of the selected channel 308 a. Thisallows for drilling at or near the damaged area of the plantar plate ina precise manner.

With reference specifically to FIG. 6, an exemplary plantar plate jointdistractor 600 can be seen. As will be appreciated by those of skill inthe art, the plantar plate joint distractor 600 can be utilized tospread muscle or other human tissue. The plantar plate joint distractor600 is configured to expand and retract sections of tissue at or nearthe plantar plate. FIG. 7 depicts the plantar plate joint distractor 600in a closed configuration 700 along a spreader opening path 702, whileFIG. 8 depicts the plantar plate joint distractor 600 in an openconfiguration 800 along the spreader opening path 702.

In some embodiments, the plantar plate joint distractor 600 may bemechanically or electro-mechanically placed in the spreader opening path702 using, for example, a bolt-thread mechanism 602. The bolt-threadmechanism 602 may include a threaded lever that moves a pair of clampsdistally and proximally relative to each other. The plantar plate jointdistractor 600 can also be seen having two apertures 604 a, 604 bdisposed toward the distal ends 606 of the plantar plate jointdistractor 600, which are configured to receive at least two K-wire,described below.

With reference specifically to FIGS. 9-10, the kit assembly 100 alsoincludes a drill bit 900. The drill bit 900 is used to drive the graftinto position at the damaged area of the plantar plate 2002 (See FIG.27). The drill bit 900 may also be used to remove tissue material andform a hole at or near the damaged area of the plantar plate. The drillbit 900 is defined by a body portion 902 that terminates at a drill head906. The body portion 902 is approximately 2.7 mm in diameter. Howeverin other embodiments, larger or smaller diameters, however, may beutilized. The chuck end 904 of the drill bit 900 may be shaped and sizedfor insertion within the drill insertion member 310. A power drill thencouples to the check end 904 of the drill bit 900 for driving into theplantar plate.

With reference specifically to FIGS. 11-12, a graft passer 1100 isemployed to facilitate in the handling of a soft tissue graft 1800,e.g., an Artelon Graft (shown in FIGS. 18-19). The graft passer 1100 hasa handle end 1102 for controlling the graft passer 1100, and a loop 1104that retains the graft 1800 during manipulation. The loop shape of thegraft passer 1100 encircles the graft 1800 for alignment across thedamaged area of the plantar plate during augmentation thereof.

With reference specifically to FIG. 13, the kit assembly 100 provides atleast two K-wires 1300 a, 1300 b that attach to the graft, so as to helpmanipulate the graft to the desired position across the damaged plantarplate 2002. The K-wires 1300 a-b may also be driven into the tissue ofthe plantar plate for retaining the augmented tissue in the desiredposition; serving as anchors therein. The K-wires 1300 a-b are anchoredfrom one end to the apertures 604 a-b in the distal end 606 of theplantar plate joint distractor 600. In this manner, moving the plantarplate joint distractor 600 between the open and closed configurations800, 700 works to adjust the position of the K-wires 1300 a-b.

The K-wires 1300 a-b may also include Kirschner wires. The two K-wire1300 a-b may be each approximately 0.45″ in diameter. Though inalternative embodiments, greater or smaller diameters may be used.K-wires 1300 a-b can also be considered to be a pin. In one non-limitingembodiment, the K-wire 1300 a-b is a section of sterilized, sharpened,smooth stainless steel pin.

With reference specifically to FIGS. 14-15, the kit assembly alsoprovides two interference type screws 1400 a, 1400 b. The interferencetype screws 1400 a, 1400 b provide a direct tendon-to-bone interferencefixation device for securing the K-wires 1300 a-b and graft 1800 intoplace. The interference type screws 1400 a, 1400 b are defined by screwthreads 1402 that engage and compress the graft 1800 for fixation.

As FIGS. 16-17 show, the kit assembly 100 also provides a screw driver1600 defined by a proximal end 1602 and a distal end 1604. Theinterference type screws 1400 a, 1400 b detachably attach to the distalend 1604 of the screw driver 1600, such that the screw drivermanipulates and inserts the interference type screws 1400 a, 1400 bthrough the graft 1800 and K-wire ends during the surgical procedure.

FIGS. 1-27 are described in conjunction with the process flow chart ofFIG. 28. Although FIG. 28 shows a specific order of executing theprocess steps, the order of executing the steps may be changed relativeto the order shown in certain embodiments. Also, two or more blocksshown in succession may be executed concurrently or with partialconcurrence in some embodiments. Certain steps may also be omitted inFIG. 28 for the sake of brevity. In some embodiments, some or all of theprocess steps included in FIG. 28 can be combined into a single process.

In some embodiments, a method 2800 of repairing plantar plate tearsthrough augmentation includes an initial Step 2802 of cutting anincision above a damaged area of a plantar plate. The area is markedprior to cutting in order to determine the appropriate incisionlocation. The method 2800 may further comprise a Step 2804 of spreadingthe tissue at or near the plantar plate with a plantar plate jointdistractor 600, whereby the plantar plate joint distractor isselectively expanded to an open configuration 800 along a spreaderopening path 702. FIG. 21 illustrates the plantar plate joint distractor600 separating the skin to expose the damaged tendons at or near theplantar plate 2002. A bolt mechanism 602 can be manually turned to urgethe plantar plate joint distractor 600 between the open and closedpositions.

As illustrated in FIG. 22, a Step 2806 includes positioning a plantardrill guide over the plantar plate, the plantar drill guide comprising amain body, a support member, and a drill receiving platform, the mainbody being defined by a plurality of channels sloped at multiple angles.The plantar plate drill guide 300 is used to position over a damagedarea of a plantar plate, so as to align a drill for drilling therein.The drill insertion member fits into the appropriate channel to guidethe drill bit into the tissue (FIG. 23).

In some embodiments, a Step 2808 comprises inserting a drill insertionmember into one of the channels, the selected channel being dependent ona drilling angle over the tissue. The drill insertion member is acylindrical component that helps guide the drill to the appropriatelocation above the plantar plate 2002. A Step 2810 includes attaching atleast two K-wires to a graft (FIG. 24). The graft is an FDA approvedsoft tissue graft, including an Artelon graft. The K-wire is used topull and manipulate the graft to the desired position across the damagedarea pf the plantar plate 2002. FIG. 25 shows the graft positionedacross the plantar plate, serving as an augmentation thereof. At thisstage of the procedure, the plantar plate drill guide has been removedto provide space to manipulate the graft.

Turning now to FIG. 26, a Step 2812 may include pulling, with theK-wire, the graft across a damaged area of the plantar plate, wherebythe graft augments the damaged area of the plantar plate. As shown inFIG. 27, a Step 2814 comprises passing a drill bit through the graft.The drill bit drives the graft across the damaged area of the plantarplate. The method may further comprise a Step 2816 of drilling, with thedrill bit, the tissue at or near the damaged area of the plantar plate.Once manipulated to the desired position for augmentation, the ends ofthe K-wires can be drilled into the tissue, serving as an anchorthereto.

In some embodiments, the method 2800 further includes a Step 2818includes manipulating, with a screw driver, at least twointerference-type screws through the K-wires, the graft, and the plantarplate. A final Step 2820 includes removing, after a duration, theK-wires from the graft, whereby the damaged area of the plantar plate ishealed.

Although the process-flow diagrams show a specific order of executingthe process steps, the order of executing the steps may be changedrelative to the order shown in certain embodiments. Also, two or moreblocks shown in succession may be executed concurrently or with partialconcurrence in some embodiments. Certain steps may also be omitted fromthe process-flow diagrams for the sake of brevity. In some embodiments,some or all the process steps shown in the process-flow diagrams can becombined into a single process.

These and other advantages of the invention will be further understoodand appreciated by those skilled in the art by reference to thefollowing written specification, claims and appended drawings. Becausemany modifications, variations, and changes in detail can be made to thedescribed preferred embodiments of the invention, it is intended thatall matters in the foregoing description and shown in the accompanyingdrawings be interpreted as illustrative and not in a limiting sense.Thus, the scope of the invention should be determined by the appendedclaims and their legal equivalence.

What is claimed is:
 1. A single-use plantar plate augmentation kitassembly, the assembly comprising: a plantar plate joint distractorconfigured to separate tissue, the plantar plate joint distractoroperational between a closed position and an open position along aspreader opening path, the plantar plate joint distractor defined by adistal end forming two apertures configured to receive at least twoK-wires; a plantar plate drill guide comprising a main body, a supportmember coupled to the main body, and a drill receiving platform, themain body of the plantar plate guide being defined by a plurality ofchannels, the channels being sloped at multiple angles; a drillinsertion member defined by a proximal opening and a distal openingadapted to retain a drill bit, the drill insertion member sized anddimensioned to fit in the channels, whereby the drill bit is capable ofbeing selectively oriented towards at least one of the angles of thechannels; a graft passer defined by a handle end and a loop, wherein theloop is capable of retaining a graft; at least two interference screws,the interference screws defined by screw threads configured to engageand compress the graft for fixation; and a screw driver defined by aproximal end and a distal end, the distal end detachably attachable tothe interference type screws, Whereby the screw driver, in use,manipulates the interference-type screws into the graft.
 2. Thesingle-use plantar plate augmentation kit assembly according to claim 1,wherein the support member is disposed at an orthogonal orientation withrespect to the main body.
 3. The single-use plantar plate augmentationkit assembly according to claim 1, wherein the support member, in use,couples to the main body through a fastener.
 4. The single-use plantarplate augmentation kit assembly according to claim 3, wherein thefastener includes at least one of the following: a screw, a bolt, anadhesive, and a compression fitting.
 5. The single-use plantar plateaugmentation kit assembly according to claim 1, wherein the drillinsertion member is removably couplable through the channels in afriction fit relationship.
 6. The single-use plantar plate augmentationkit assembly according to claim 1, wherein the K-wires have a diameterof about 0.45 inches.
 7. The single-use plantar plate augmentation kitassembly according to claim 1, wherein the plantar plate jointdistractor comprises: a bolt-thread mechanism.
 8. The single-use plantarplate augmentation kit assembly according to claim 1, wherein the drillbit comprises a chuck end and the drill bit is shaped and sized forinsertion in the drill insertion member.
 9. The single-use plantar plateaugmentation kit assembly according to claim 1, wherein the drill bit isdefined by a drill head and a body portion having a diameter of about2.7 millimeters.
 10. The single-use plantar plate augmentation kitassembly according to claim 1, wherein the K-wires comprise: asterilized, sharpened, smooth stainless-steel pin.
 11. The single-useplantar plate augmentation kit assembly according to claim 1, furthercomprising: a container defined by an outer housing and multiple innerrecesses, the recesses being shaped and sized to frictionally fit atleast one of the following: the plantar plate drill guide, the plantarplate joint distractor, the K-wires, the drill bit, the graft passer,the interference-type screws, and the screw driver.
 12. A single-useplantar plate augmentation kit assembly, the assembly comprising: aplantar plate joint distractor configured to separate tissue, theplantar plate joint distractor comprising a bolt-thread mechanismconfigured to operate the plantar plate joint distractor between aclosed position and an open position along a spreader opening path, theplantar plate joint distractor defined by a distal end forming twoapertures configured to receive at least two K-wires having a diameterof about 0.45 inches; a plantar plate drill guide comprising a mainbody, a support member coupled to the main body at an orthogonalorientation, and a drill receiving platform, the main body of theplantar plate guide being defined by a plurality of channels, thechannels being sloped at multiple angles; a drill insertion memberdefined by a proximal opening and a distal opening adapted to retain adrill bit the drill bit being defined by a chuck end shaped and sizedfor insertion in the drill insertion member, the drill insertion memberbeing sized and dimensioned to fit in the channels, whereby the drillbit is capable of being selectively oriented towards at least one of theangles of the channels; a graft passer defined by a handle end and aloop, wherein the loop is capable of retaining a graft; at least twointerference screws, the interference screws defined by screw threadsconfigured to engage and compress the graft for fixation; a screw driverdefined by a proximal end and a distal end, the distal end detachablyattachable to the interference type screws, whereby the screw driver, inuse, manipulates the interference-type screws into the graft; and acontainer defined by an outer housing and multiple inner recesses, therecesses being shaped and sized to frictionally fit at least one of thefollowing: the plantar plate drill guide, the plantar plate jointdistractor, the K-wires, the drill hit, the graft passer, theinterference-type screws, and the screw driver.
 13. The single-useplantar plate augmentation kit assembly according to claim 12, whereinthe support member, in use, couples to the main body through a fastener.14. The single-use plantar plate augmentation kit assembly according toclaim 13, wherein the fastener includes at least one of the following: ascrew, a bolt, an adhesive, and a compression fitting.
 15. Thesingle-use plantar plate augmentation kit assembly according to claim12, wherein the drill insertion member is removably couplable throughthe channels in a friction fit relationship.
 16. The single-use plantarplate augmentation kit assembly according to claim 12, wherein the drillbit has a diameter of about 2.7 millimeters.
 17. The single-use plantarplate augmentation kit assembly according to claim 12, wherein theK-wires comprise: a sterilized, sharpened, smooth stainless-steel pin.